# K063580: Sonoace X8 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Dec 14, 2006 after 14 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924432 (1993). 15 ancestors in all.
129 later devices descend from it; 5 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052911: Accuvix XQ Diagnostic Ultrasound System, Medison Co., Ltd. (2005) Summary page 1.
- K013627: Sonoace SA-8000 Diagnostic Ultrasound System, Medison America, Inc. (2001) Summary page 1.

## Most influential descendants
- K070813: Accuvix V10 Diagnostic Ultrasound System (2007), 125 descendants of its own
- K080800: Accuvix V20 Diagnostic Ultrasound System (2008), 124 descendants of its own
- K092159: Accuvix V20 Diagnostic Ultrasound System (2009), 123 descendants of its own
- K093849: Accuvix V10 Diagnostic Ultrasound System (2010), 112 descendants of its own
- K101455: Eko 7 Diagnostic Ultrasound System (2010), 111 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K063580
Methodology: https://510kreport.com/methodology